Biologically adherent polymeric microsphere carriers have been shown to be effective in the oral delivery of proteins such as insulin. These microspheres are comprised of hydrophobic copolymers, in contrast to conventional microspheres that are hydrophilic in nature. The hydrophobic microspheres appear to have a significantly longer residence time in the gastrointestinal tract as compared to conventional microspheres. While highly promising, the hydrophobic microspheres still present challenges in terms of manufacturing and formulation of a clinically acceptable product. Typically, the microspheres are produced from an organic solvent solution, which raises concerns regarding deleterious effects on the therapeutic protein and residual organic solvent in the final product as well as manufacturing scalability and environmental impact.
The issued patent covers novel methods for manufacturing biodegradable polymer microspheres and nanospheres utilizing nontoxic supercritical or near-critical fluids with or without polar cosolvents. According to the inventor, Trevor Castor, "This technology can be utilized to enhance the oral bioavailability of therapeutic proteins and improve biotechnology drugs industrialization through market acceptability and patient compliance, and can also be utilized as controlled release vehicles for potent viral antigens against extreme infectious diseases."
Attorneys of record are Dr. Stephen J. Gaudet, now of McDermott Will & Emery LLP, Boston, MA and Dr. Janine M. Susan of Burns & Levinson LLP, Boston, MA.
Aphios Corporation is a biopharmaceutical company that is developing enabling technology platforms and enhanced therapeutic products for the prevention and treatment of certain cancers, infectious diseases and CNS disorders.